1.0 OBJECTIVE

To lay down the procedure for action
to be taken during unusual observation for instrument duringcalibration.

2.0 SCOPE

This procedure is applicable to
instrument which are calibrated in quality control department.

3.0 RESPONSIBILITY

3.1 Doing : Technical Assistant

3.2 Checking : Executive/Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 Q.C. Assistant calibrating the
instrument shall inform to the concerned Executive regarding theout of calibration incidence of the instrument.

5.2 Q.C. Executive shall go through the problem
arised and shall try to rectifythe
problem if possiblewithin available parameters and guideline received
from manufacturer.

5.3 He shall inform to maintenance
department if the problem is not rectified or solved.

5.4 If the problem is arised of other technical nature and
can not be rectified, he shall inform with the details of the problemtothe authorized service center or manufacturer regarding the nature ofthe problem and intimate them to send the service
engineer to rectify the problem at the earliest.

5.5 After servicing the instrument by service engineer re-calibrate the instrument as per respective SOP’sand keep the record of the same. Note down the details in
respective instrument history card.

5.6 Analyse the product/batch which was last analysed on
that particular instrument to confirm the result.

5.7 The difference between the initial
result & the new result after re-calibration should not differ by more than
1%.

5.8 If the result of the last analysed
batch/product is not within this+1% of initial result then select
second last batch/product for analysis and continued doing testing of the
batches/product in reverse order till the results are found within the+1% of the initial result.

5.9 List out the batches not complying the+1% criteria and ensure that the
revised results comply with specified limit as per release specification.

5.10 In case if does not comply with release specification,
ensure that it complies with regulatory specification.

5.11 In case if it is not complies with regulatory
specification then inform to manager QC for further action.

5.12 In case of raw material/list out the RM
if the revised results not comply with+1% criteria.

5.13 Ensure that the revised results of
listed RM are complies with laid down specifications.

5.14 In case if it is found not complies, immediately instruct RM store to stop the further use through proper channel and inform to QC Incharge for further action.